j Joan
on

 

Hi,

It is sometimes convenient, as a contractor, to run checks quickly for SDTM datasets with the new Community 3_0 without running in Enterprise, which requires creating project and study setup.  I expect the rules to be roughly consistent with Enterprise, if I'm using new Community version 3.0.

However, for SDTM IG 3.2 (FDA validation),  I'm finding differences in rules existence or severity, with rules stricter sometimes in Community 3.0 than in Enterprise.  For example, for rules related to date logic and limit errors, "FDAB034", the Community 3_0 cites an fda Error for the SD1204 condition of:    --ENDTC date is after RFPENDTC   (such as AEENDTC), but P21E rates that rule as "NA" for FDA severity, and as a Warning for PMDA.

Similarly, Community 3_0 cites FDA error for SD1331,"DSSTDTC is after DSDTC" but the rule may not even exist for P21 Enterprise.

The list of rules on the website, at https://www.pinnacle21.com/validation-rules/sdtm  seems to correspond more to Community than P21 E, which I suppose makes sense.

Can you please advise on the differences between Community 3_0 and Pinnacle 21 Enterprise for SDTM IG 3.2 for FDA -- why the Community version may be stricter? 

Should we be disregarding some of the violation flags for dates logic we see that fire in Community 3_0?

Thanks very much,

- Joan

Forums: SDTM

Trevor
on August 14, 2019

Hi Joan,

As you are an Enterprise customer, please log this in our Support Desk and we will be sure to get your questions addressed. This forum is for answering questions specific to Community.

Thanks,

Trevor

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